Download PDF

Clinical Trial Results:
Investigation of once-weekly semaglutide s.c. dose-response in patients with type 2 diabetes and overweight - a participant- and investigator-blinded and sponsor open-label study.

Summary
EudraCT number	2022-000882-41
Trial protocol	HU GR PL
Global end of trial date	13 Dec 2023

Results information
Results version number	v1(current)
This version publication date	27 Dec 2024
First version publication date	27 Dec 2024
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

NN9535-4984

ISRCTN number

US NCT number

NCT05486065

WHO universal trial number (UTN)

Sponsor organisation name

Novo Nordisk A/S

Sponsor organisation address

Novo Allé, Bagsvaerd, Denmark, 2880

Public contact

Clinical Reporting Office (2834), Novo Nordisk A/S, clinicaltrials@novonordisk.com

Scientific contact

Clinical Reporting Office (2834), Novo Nordisk A/S, clinicaltrials@novonordisk.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

09 Feb 2024

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

13 Dec 2023

Was the trial ended prematurely?

Main objective of the trial

To characterise the dose-response curve of once weekly semaglutide s.c. for change in HbA1c from baseline to week 40 in patients with type 2 diabetes (T2D) and body mass index (BMI) ≥ 27 kg/m2 as an add-on to a stable dose of metformin.

Protection of trial subjects

The trial was conducted in accordance with the Declaration of Helsinki (Oct 2013) and International Council for Harmonisation (ICH) Good Clinical Practice, including archiving of essential documents (May 1996) and European Norm (EN) International Organization for Standardization (ISO) 14155 Part 1 and 2 and Food and Drug Administration (FDA) 21 Code of Federal Regulations (CFR) 312.120.

Background therapy

Evidence for comparator

Actual start date of recruitment

08 Aug 2022

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Greece: 54

Country: Number of subjects enrolled

Hungary: 35

Country: Number of subjects enrolled

Poland: 33

Country: Number of subjects enrolled

United States: 123

Worldwide total number of subjects

245

EEA total number of subjects

122

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

245

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

This study was conducted at 82 active sites in 4 countries, of which 75 sites enrolled subjects.

Screening details

Subjects were randomized at a ratio of 3:1:3:1:3:1 to receive semaglutide (2 mg, 8 mg, 16 mg) or matching placebo.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Semaglutide 2.0 mg

Arm description

Subjects received once-weekly subcutaneous (s.c.) injections of semaglutide (in a dose-escalation manner once in every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg], followed by the maintenance dose of 2 mg) till 40 weeks.

Arm type

Experimental

Investigational medicinal product name

Semaglutide

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received once weekly s.c. injections of semaglutide for 40 weeks.

Semaglutide 8.0 mg

Arm description

Subjects received once-weekly s.c. injections of semaglutide (in a dose-escalation manner once in every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg], followed by the maintenance dose of 8 mg) till 40 weeks.

Arm type

Experimental

Investigational medicinal product name

Semaglutide

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received once weekly s.c. injections of semaglutide for 40 weeks.

Semaglutide 16.0 mg

Arm description

Subjects received once-weekly s.c. injections of semaglutide (in a dose-escalation manner once in every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg; 21-24 weeks: 8.06 mg], followed by the maintenance dose of 16 mg) till 40 weeks.

Arm type

Experimental

Investigational medicinal product name

Semaglutide

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received once weekly s.c. injections of semaglutide for 40 weeks.

Placebo

Arm description

Subjects received once-weekly s.c. injection of placebo matched to semaglutide for 40 weeks.

Arm type

Placebo

Investigational medicinal product name

Semaglutide placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received once weekly s.c. injections of placebo matched to semaglutide for 40 weeks.

Number of subjects in period 1	Semaglutide 2.0 mg	Semaglutide 8.0 mg	Semaglutide 16.0 mg	Placebo
Started	61	62	62	60
Full analysis set	61	62	62	60
Safety analysis set	60	60	62	59
Completed	56	54	55	54
Not completed	5	8	7	6
Consent withdrawn by subject	1	5	4	3
Physician decision	-	1	1	-
Failure to meet randomization criteria	-	-	-	1
Lost to follow-up	4	2	2	2

Baseline characteristics

Top of page

Reporting group title

Semaglutide 2.0 mg

Reporting group description

Reporting group title

Semaglutide 8.0 mg

Reporting group description

Reporting group title

Semaglutide 16.0 mg

Reporting group description

Subjects received once-weekly s.c. injections of semaglutide (in a dose-escalation manner once in every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg; 21-24 weeks: 8.06 mg], followed by the maintenance dose of 16 mg) till 40 weeks.

Reporting group title

Placebo

Reporting group description

Subjects received once-weekly s.c. injection of placebo matched to semaglutide for 40 weeks.

Reporting group values	Semaglutide 2.0 mg	Semaglutide 8.0 mg	Semaglutide 16.0 mg	Placebo	Total
Number of subjects	61	62	62	60	245
Age categorical
Units: Subjects
Age Continuous
Units: years
arithmetic mean (standard deviation)	52.3 ( 7.6 )	53.7 ( 7.5 )	52.9 ( 8.6 )	52.1 ( 9.5 )	-
Sex: Female, Male
Units: Subjects
Female	27	33	25	35	120
Male	34	29	37	25	125
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	0	0	0	0
Asian	1	1	0	1	3
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	6	11	4	4	25
White	54	49	56	55	214
More than one race	0	0	2	0	2
Unknown or Not Reported	0	1	0	0	1
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	9	8	9	13	39
Not Hispanic or Latino	52	54	53	47	206
Unknown or Not Reported	0	0	0	0	0

End points

Top of page

Reporting group title

Semaglutide 2.0 mg

Reporting group description

Reporting group title

Semaglutide 8.0 mg

Reporting group description

Reporting group title

Semaglutide 16.0 mg

Reporting group description

Subjects received once-weekly s.c. injections of semaglutide (in a dose-escalation manner once in every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg; 21-24 weeks: 8.06 mg], followed by the maintenance dose of 16 mg) till 40 weeks.

Reporting group title

Placebo

Reporting group description

Subjects received once-weekly s.c. injection of placebo matched to semaglutide for 40 weeks.

Primary: Change in glycated haemoglobin (HbA1c)

Top of page

End point title

Change in glycated haemoglobin (HbA1c)

End point description

Change in HbA1c from baseline (week 0) to end of treatment (week 40) is presented. Full analysis set included all randomised subjects. Here, "Overall Number of Subjects Analyzed" signifies those subjects who were evaluable for this outcome measure.

End point type

Primary

End point timeframe

Baseline (week 0) and End of treatment (week 40)

End point values	Semaglutide 2.0 mg	Semaglutide 8.0 mg	Semaglutide 16.0 mg	Placebo
Number of subjects analysed	56	57	56	54
Units: Percentage-point of HbA1c
arithmetic mean (standard deviation)	-1.9 ( 1.1 )	-1.8 ( 1.5 )	-2.1 ( 1.5 )	-1.1 ( 1.3 )

Semaglutide 2.0 mg - Placebo

Comparison groups

Semaglutide 2.0 mg v Placebo

Number of subjects included in analysis

110

Analysis specification

Pre-specified

Analysis type

^[1]

P-value

= 0.0002

Method

ANCOVA

Parameter type

Treatment difference

Point estimate

-0.82

Confidence interval

level

95%

sides

2-sided

lower limit

-1.25

upper limit

-0.39

Notes
[1] - The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.

Semaglutide 16.0 mg - Semaglutide 2.0 mg

Comparison groups

Semaglutide 2.0 mg v Semaglutide 16.0 mg

Number of subjects included in analysis

112

Analysis specification

Pre-specified

Analysis type

^[2]

P-value

= 0.2445

Method

ANCOVA

Parameter type

Treatment difference

Point estimate

-0.25

Confidence interval

level

95%

sides

2-sided

lower limit

-0.67

upper limit

0.17

Notes
[2] - The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.

Semaglutide 8.0 mg vs Semaglutide 2.0 mg

Statistical analysis description

The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.

Comparison groups

Semaglutide 2.0 mg v Semaglutide 8.0 mg

Number of subjects included in analysis

113

Analysis specification

Pre-specified

Analysis type

P-value

= 0.8305

Method

ANCOVA

Parameter type

Treatment difference

Point estimate

0.05

Confidence interval

level

95%

sides

2-sided

lower limit

-0.38

upper limit

0.47

Semaglutide 16.0 mg - Semaglutide 8.0 mg

Comparison groups

Semaglutide 8.0 mg v Semaglutide 16.0 mg

Number of subjects included in analysis

113

Analysis specification

Pre-specified

Analysis type

^[3]

P-value

= 0.1678

Method

ANCOVA

Parameter type

Treatment difference

Point estimate

-0.3

Confidence interval

level

95%

sides

2-sided

lower limit

-0.72

upper limit

0.13

Notes
[3] - The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.

Semaglutide 8.0 mg vs Placebo

Comparison groups

Semaglutide 8.0 mg v Placebo

Number of subjects included in analysis

111

Analysis specification

Pre-specified

Analysis type

^[4]

P-value

= 0.0003

Method

ANCOVA

Parameter type

Treatment difference

Point estimate

-0.77

Confidence interval

level

95%

sides

2-sided

lower limit

-1.19

upper limit

-0.35

Notes
[4] - The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.

Sema 16.0 mg vs Placebo

Comparison groups

Semaglutide 16.0 mg v Placebo

Number of subjects included in analysis

110

Analysis specification

Pre-specified

Analysis type

^[5]

P-value

< 0.0001

Method

ANCOVA

Parameter type

Treatment difference

Point estimate

-1.07

Confidence interval

level

95%

sides

2-sided

lower limit

-1.5

upper limit

-0.64

Notes
[5] - The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.

Secondary: Change in body weight

Top of page

End point title

Change in body weight

End point description

Change in body weight from baseline (week 0) to end of treatment (week 40) is presented. Full analysis set included all randomised subjects. Here, "Overall Number of Subjects Analyzed" signifies those subjects who were evaluable for this outcome measure.

End point type

Secondary

End point timeframe

Baseline (week 0) and End of treatment (week 40)

End point values	Semaglutide 2.0 mg	Semaglutide 8.0 mg	Semaglutide 16.0 mg	Placebo
Number of subjects analysed	56	56	55	53
Units: Kilogram (kg)
arithmetic mean (standard deviation)	-8.9 ( 8.5 )	-10.1 ( 7.4 )	-13.1 ( 8.4 )	-2.3 ( 4.9 )

No statistical analyses for this end point

Secondary: Number of treatment-emergent severe hypoglycaemic episodes

Top of page

End point title

Number of treatment-emergent severe hypoglycaemic episodes

End point description

Number of treatment-emergent severe Hypoglycaemic episodes are presented. Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. On treatment observation period data are presented. On-treatment oberservation period is defined as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. DPS1 in trial is defined as all observed data points from randomisation until the first date of end of study visit or date of death or date of withdrawal of informed consent or date of last contact as defined by investigator for subjects that are lost to follow up. Safety analysis set included all subjects who are exposed to randomised treatment.

End point type

Secondary

End point timeframe

From baseline (week 0) up to end of study (week 49)

End point values	Semaglutide 2.0 mg	Semaglutide 8.0 mg	Semaglutide 16.0 mg	Placebo
Number of subjects analysed	60	60	62	59
Units: Episodes
number (not applicable)	0	0	0	0

No statistical analyses for this end point

Secondary: Number of treatment-emergent adverse events (TEAEs)

Top of page

End point title

Number of treatment-emergent adverse events (TEAEs)

End point description

AE is any untoward medical occurrence in a clinical study subjects that is temporally associated with use of investigational medicinal products (IMP), whether or not considered related to IMP. AE can therefore be any unfavourable & unintended sign, symptom or disease (new/exacerbated) temporally associated with use of IMP. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment observation period is defined as time points from first drug date until first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. DPS1 in trial is defined as all observed data points from randomisation until first date of end of study visit or date of death or date of withdrawal of informed consent or contact as defined by investigator for subjects that are lost to follow up. Safety analysis set included all subjects who are exposed to randomised treatment.

End point type

Secondary

End point timeframe

From baseline (week 0) up to end of study (week 49)

End point values	Semaglutide 2.0 mg	Semaglutide 8.0 mg	Semaglutide 16.0 mg	Placebo
Number of subjects analysed	60	60	62	59
Units: Events
number (not applicable)	43	54	55	37

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

From baseline (week 0) up to end of study (week 49)

Adverse event reporting additional description

AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. Safety analysis set included all subjects who are exposed to randomised treatment.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

Reporting group title

Sema 16.0 mg

Reporting group description

Subjects received once-weekly s.c. injections of semaglutide (in a dose-escalation manner once in every 4 weeks [0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg; 21-24 weeks: 8.06 mg], followed by the maintenance dose of 16 mg) till 40 weeks.

Reporting group title

Sema 2.0 mg

Reporting group description

Reporting group title

Placebo

Reporting group description

Subjects received once-weekly s.c. injection of placebo matched to semaglutide for 40 weeks.

Reporting group title

Sema 8.0 mg

Reporting group description

Serious adverse events	Sema 16.0 mg	Sema 2.0 mg	Placebo	Sema 8.0 mg
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 62 (1.61%)	4 / 60 (6.67%)	2 / 59 (3.39%)	2 / 60 (3.33%)
number of deaths (all causes)	0	0	0	0
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
subjects affected / exposed	0 / 62 (0.00%)	1 / 60 (1.67%)	0 / 59 (0.00%)	0 / 60 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Incisional hernia
subjects affected / exposed	0 / 62 (0.00%)	1 / 60 (1.67%)	0 / 59 (0.00%)	0 / 60 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Post procedural haemorrhage
subjects affected / exposed	0 / 62 (0.00%)	1 / 60 (1.67%)	0 / 59 (0.00%)	0 / 60 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Cardiac failure chronic
subjects affected / exposed	0 / 62 (0.00%)	0 / 60 (0.00%)	0 / 59 (0.00%)	1 / 60 (1.67%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	0 / 62 (0.00%)	0 / 60 (0.00%)	1 / 59 (1.69%)	0 / 60 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Inguinal hernia
subjects affected / exposed	0 / 62 (0.00%)	0 / 60 (0.00%)	0 / 59 (0.00%)	1 / 60 (1.67%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pancreatitis acute
subjects affected / exposed	0 / 62 (0.00%)	0 / 60 (0.00%)	1 / 59 (1.69%)	0 / 60 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Cholecystitis acute
subjects affected / exposed	1 / 62 (1.61%)	0 / 60 (0.00%)	0 / 59 (0.00%)	0 / 60 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Vestibular neuronitis
subjects affected / exposed	0 / 62 (0.00%)	1 / 60 (1.67%)	0 / 59 (0.00%)	0 / 60 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Sema 16.0 mg	Sema 2.0 mg	Placebo	Sema 8.0 mg
Total subjects affected by non serious adverse events
subjects affected / exposed	50 / 62 (80.65%)	30 / 60 (50.00%)	29 / 59 (49.15%)	48 / 60 (80.00%)
Investigations
Glycosylated haemoglobin increased
subjects affected / exposed	0 / 62 (0.00%)	0 / 60 (0.00%)	3 / 59 (5.08%)	1 / 60 (1.67%)
occurrences all number	0	0	3	1
Lipase increased
subjects affected / exposed	3 / 62 (4.84%)	3 / 60 (5.00%)	1 / 59 (1.69%)	2 / 60 (3.33%)
occurrences all number	3	3	2	2
Vascular disorders
Hypertension
subjects affected / exposed	0 / 62 (0.00%)	1 / 60 (1.67%)	2 / 59 (3.39%)	3 / 60 (5.00%)
occurrences all number	0	1	2	3
Nervous system disorders
Dizziness
subjects affected / exposed	3 / 62 (4.84%)	2 / 60 (3.33%)	4 / 59 (6.78%)	6 / 60 (10.00%)
occurrences all number	3	2	5	6
Headache
subjects affected / exposed	7 / 62 (11.29%)	2 / 60 (3.33%)	8 / 59 (13.56%)	6 / 60 (10.00%)
occurrences all number	9	6	23	13
Hyperaesthesia
subjects affected / exposed	5 / 62 (8.06%)	0 / 60 (0.00%)	0 / 59 (0.00%)	0 / 60 (0.00%)
occurrences all number	6	0	0	0
Paraesthesia
subjects affected / exposed	5 / 62 (8.06%)	0 / 60 (0.00%)	0 / 59 (0.00%)	0 / 60 (0.00%)
occurrences all number	5	0	0	0
General disorders and administration site conditions
Fatigue
subjects affected / exposed	6 / 62 (9.68%)	2 / 60 (3.33%)	2 / 59 (3.39%)	4 / 60 (6.67%)
occurrences all number	7	3	2	4
Gastrointestinal disorders
Abdominal distension
subjects affected / exposed	3 / 62 (4.84%)	2 / 60 (3.33%)	1 / 59 (1.69%)	4 / 60 (6.67%)
occurrences all number	3	3	1	4
Abdominal pain upper
subjects affected / exposed	2 / 62 (3.23%)	5 / 60 (8.33%)	3 / 59 (5.08%)	5 / 60 (8.33%)
occurrences all number	3	5	4	6
Abdominal pain
subjects affected / exposed	4 / 62 (6.45%)	3 / 60 (5.00%)	1 / 59 (1.69%)	1 / 60 (1.67%)
occurrences all number	4	3	1	1
Diarrhoea
subjects affected / exposed	13 / 62 (20.97%)	9 / 60 (15.00%)	7 / 59 (11.86%)	20 / 60 (33.33%)
occurrences all number	19	29	56	30
Dry mouth
subjects affected / exposed	0 / 62 (0.00%)	3 / 60 (5.00%)	0 / 59 (0.00%)	2 / 60 (3.33%)
occurrences all number	0	3	0	2
Dyspepsia
subjects affected / exposed	5 / 62 (8.06%)	5 / 60 (8.33%)	1 / 59 (1.69%)	5 / 60 (8.33%)
occurrences all number	13	5	1	5
Eructation
subjects affected / exposed	5 / 62 (8.06%)	3 / 60 (5.00%)	1 / 59 (1.69%)	3 / 60 (5.00%)
occurrences all number	8	3	2	3
Constipation
subjects affected / exposed	12 / 62 (19.35%)	2 / 60 (3.33%)	3 / 59 (5.08%)	8 / 60 (13.33%)
occurrences all number	16	2	3	11
Gastrooesophageal reflux disease
subjects affected / exposed	3 / 62 (4.84%)	1 / 60 (1.67%)	1 / 59 (1.69%)	4 / 60 (6.67%)
occurrences all number	3	1	1	4
Flatulence
subjects affected / exposed	1 / 62 (1.61%)	2 / 60 (3.33%)	0 / 59 (0.00%)	3 / 60 (5.00%)
occurrences all number	1	2	0	3
Vomiting
subjects affected / exposed	16 / 62 (25.81%)	11 / 60 (18.33%)	4 / 59 (6.78%)	14 / 60 (23.33%)
occurrences all number	32	16	4	26
Nausea
subjects affected / exposed	23 / 62 (37.10%)	13 / 60 (21.67%)	9 / 59 (15.25%)	25 / 60 (41.67%)
occurrences all number	29	17	18	54
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	2 / 62 (3.23%)	0 / 60 (0.00%)	4 / 59 (6.78%)	1 / 60 (1.67%)
occurrences all number	2	0	6	1
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	6 / 62 (9.68%)	1 / 60 (1.67%)	2 / 59 (3.39%)	0 / 60 (0.00%)
occurrences all number	7	1	4	0
Infections and infestations
COVID-19
subjects affected / exposed	1 / 62 (1.61%)	1 / 60 (1.67%)	3 / 59 (5.08%)	8 / 60 (13.33%)
occurrences all number	1	1	3	8
Nasopharyngitis
subjects affected / exposed	3 / 62 (4.84%)	3 / 60 (5.00%)	2 / 59 (3.39%)	1 / 60 (1.67%)
occurrences all number	3	4	3	1
Upper respiratory tract infection
subjects affected / exposed	5 / 62 (8.06%)	1 / 60 (1.67%)	0 / 59 (0.00%)	1 / 60 (1.67%)
occurrences all number	5	1	0	1
Metabolism and nutrition disorders
Dyslipidaemia
subjects affected / exposed	2 / 62 (3.23%)	0 / 60 (0.00%)	0 / 59 (0.00%)	3 / 60 (5.00%)
occurrences all number	2	0	0	3
Hyperglycaemia
subjects affected / exposed	0 / 62 (0.00%)	0 / 60 (0.00%)	4 / 59 (6.78%)	1 / 60 (1.67%)
occurrences all number	0	0	4	1
Hyperlipidaemia
subjects affected / exposed	0 / 62 (0.00%)	0 / 60 (0.00%)	4 / 59 (6.78%)	1 / 60 (1.67%)
occurrences all number	0	0	4	1

More information

Top of page

Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Clinical trials

Clinical Trial Results:
Investigation of once-weekly semaglutide s.c. dose-response in patients with type 2 diabetes and overweight - a participant- and investigator-blinded and sponsor open-label study.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Change in glycated haemoglobin (HbA1c)

Primary: Change in glycated haemoglobin (HbA1c)

Secondary: Change in body weight

Secondary: Change in body weight

Secondary: Number of treatment-emergent severe hypoglycaemic episodes

Secondary: Number of treatment-emergent severe hypoglycaemic episodes

Secondary: Number of treatment-emergent adverse events (TEAEs)

Secondary: Number of treatment-emergent adverse events (TEAEs)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: Investigation of once-weekly semaglutide s.c. dose-response in patients with type 2 diabetes and overweight - a participant- and investigator-blinded and sponsor open-label study.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Change in glycated haemoglobin (HbA1c)

Primary: Change in glycated haemoglobin (HbA1c)

Secondary: Change in body weight

Secondary: Change in body weight

Secondary: Number of treatment-emergent severe hypoglycaemic episodes

Secondary: Number of treatment-emergent severe hypoglycaemic episodes

Secondary: Number of treatment-emergent adverse events (TEAEs)

Secondary: Number of treatment-emergent adverse events (TEAEs)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
Investigation of once-weekly semaglutide s.c. dose-response in patients with type 2 diabetes and overweight - a participant- and investigator-blinded and sponsor open-label study.